Model: 45504
DI: 00796494455043
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Water-Based Personal Lubricant
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7d19b772-f75a-48cb-ae41-240f1f05e258
Distribution Status:
In Commercial Distribution
DUNS Number:
067692292
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
10796494455040
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
1
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00796494455043
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00796494455043
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 60412
Name: Sexual lubricant
Definition:
A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.
FDA Product Codes
NUC
Lubricant, Personal